This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | Amplatzer™ Amulet™ Left Atrial Appendage Occluder |
| Generic Name | System, Appendage Closure, Left Atrial |
| Applicant | Abbott Medical5050 Nathan Lane Northplymouth, MN 55442 PMA NumberP200049 Supplement NumberS004 Date Received06/16/2022 Decision Date07/28/2022 Product Code NGV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-06-16 |
| Decision Date | 2022-07-28 |
| PMA | P200049 |
| Supplement | S004 |
| Product Code | NGV |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Medical 5050 Nathan Lane North plymouth, MN 55442 PMA NumberP200049 Supplement NumberS004 Date Received06/16/2022 Decision Date07/28/2022 Product Code NGV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement the Addition Of Alternate Laser Cutting And Welding Systems Used In The Manufacturing Of The Amplatzer Amulet Left Atrial Appendage Occluder |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200049 | Original Filing | |
| S004 | 2022-06-16 | 30-day Notice |
| S003 | 2021-11-05 | 30-day Notice |
| S002 | ||
| S001 | 2021-08-24 | 30-day Notice |